510(k) Report

Devices descending from K042673

235 later devices reach Zodiac Polyaxial Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—